EP0927011A1 - Zwischenwirbel-implantat - Google Patents
Zwischenwirbel-implantatInfo
- Publication number
- EP0927011A1 EP0927011A1 EP96927498A EP96927498A EP0927011A1 EP 0927011 A1 EP0927011 A1 EP 0927011A1 EP 96927498 A EP96927498 A EP 96927498A EP 96927498 A EP96927498 A EP 96927498A EP 0927011 A1 EP0927011 A1 EP 0927011A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- implant
- implant according
- ceramic material
- intervertebral
- base surface
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/10—Ceramics or glasses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
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- A61F2002/3023—Three-dimensional shapes cylindrical wedge-shaped cylinders
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
- A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/908—Bioabsorbable material
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/912—Radiolucent material
Definitions
- the invention relates to an intervertebral implant according to the preamble of claim 1.
- intervertebral implants are used in the fusion of vertebral bodies - after removal of the intervertebral disc - in particular in the area of the lumbar spine.
- One to two implants are used per intervertebral space.
- an intervertebral implant is already known in which the outward-facing front and side surfaces of the implant are coated with hydroxyl apatite or ceramic HIP material.
- a disadvantage of this known implant is the fact that the base body of the implant consists of conventional non-ceramic and therefore also non-absorbable materials.
- the invention seeks to remedy this.
- the invention has for its object to provide an intervertebral implant that can withstand the various forces acting on the spine and has a sufficiently large support on the end plates to prevent them from sinking in. It should also allow the two vertebral bodies to fuse as quickly as possible and allow the implant to be incorporated quickly, taking into account the height that the intervertebral disc assumed before removal. In the next step, the implant should be able to be replaced completely (or almost completely) by the body's own bones.
- the implant mentioned at the outset is further developed by the features of the characterizing part of independent claim 1.
- This has the advantage that the implant according to the invention - after the primary fusion has taken place - compensates for the distance (corresponding to the height of the intervertebral disc) between the two vertebral bodies during the resorption process - with adequate fusion at the same time - and that the implant after a certain time because of the resorption that occurs , is no longer detectable in the body.
- Another major advantage is the x-ray transparency of the implant, which avoids disruptive effects when assessing the surrounding bony structures.
- the intervertebral implant can be designed either as a prismatic or cylindrical body.
- the porosity of the ceramic material is at most 9% by volume, preferably at most 5% by volume. Thanks to the reduced porosity of the implant, there is high compressive strength, which is a basic requirement, especially in the lumbar region of the spine. The largest possible pressure-stable contact area from end plate to implant is important here.
- the wall thickness of the annular intervertebral implant should therefore be at least 4 mm, preferably at least 6 mm, in order to prevent the implant from sinking into the end plates.
- the density of the ceramic material is more than 2.8, preferably more than 3.1, which further improves the compressive strength of the implant.
- the implant is preferably designed as a hollow circular cylinder in order to enable the introduction of the body's own bone chips or similar biocompatible materials and thus to promote rapid fusion of the implant.
- the top surface and / or the base surface of the implant is not planar, but has grooves and / or elevations running transversely to the cylinder axis of the implant.
- This three-dimensional structuring of the top and base areas enables primary anchoring immediately after the implant has been introduced into the intervertebral space, which increases the positional stability of the implant or the rotational stability of the adjacent vertebral bodies.
- the three-dimensional structuring is preferably in the form of "waves" (elevations or stiffeners with pronounced radii) in the longitudinal and transverse directions.
- the top surface and / or the base surfaces are arranged tapering parallel or in a wedge shape in order to be able to adequately reshape the curve formation in each area of the spine (lordosis, kyphosis).
- the implant preferably has an outwardly convex top surface and / or base surface which is matched to the concave shape of the natural vertebral end plates in order to achieve a better contact zone between the implant and the end plates.
- the jacket of the intervertebral implant preferably has one or more perforations which primarily serve to hold an instrument for manipulating the implant.
- the perforations can be made both on the anterior side of the implant and in the lateral zone of the implant.
- the perforations in the lateral surface serve to promote the primary bony development of the implant.
- the positional stability of the implant can be further improved by providing the mantle of the intervertebral implant with a fine three-dimensional structure, which promotes the growth of the bone in an early phase.
- This fine structuring is preferably 0.5-1.0 mm deep with a groove width of 0.5-1.0 mm.
- the structuring can be arranged over the entire lateral surface.
- the usual ceramic materials already tested in medicine with the porosity defined according to the invention are suitable, polycrystalline ceramics in which the foreign phase fraction is less than 3, preferably less than 2, being particularly preferred % By weight.
- the compressive strength of the ceramic material is expediently 400-600 MPa, preferably 450-550 MPa.
- the intervertebral implant shown in the single figure consists essentially of a hollow cylinder with an inner space 8, longitudinal axis 3, top surface 1 and base area 2.
- the intervertebral implant essentially consists of a polycrystalline, ceramic material.
- the ceramic material has a porosity of 5% by volume, the pores being filled with air.
- the pore size is less than 100 ⁇ m, preferably less than 50 ⁇ m.
- the foreign phase portion of the ceramic material is 1.5% by weight.
- the compressive strength of the ceramic material is 500 MPa.
- the cover and base surfaces 1, 2 are intended for bone contact with the cover plates of two vertebral bodies and are designed accordingly.
- the wall thickness of the intervertebral implant is 7 mm and the density of the ceramic material is 3.2.
- the top surface 1 and the base surface 2 are not planar, but are provided with a number of grooves 4 and elevations 5 running transversely (ie radially) to the longitudinal axis 3.
- the top surface 1 and the base surface 2 are arranged tapering towards one another and are slightly convexly curved outwards.
- a perforation 7 is provided anteriorly, which is used to hold a manipulation instrument.
- the jacket is also provided with a three-dimensional structure 9, which has a depth of 0.75 mm.
- the implant shown in the single figure is filled with bone chips (bone graft or bone substitute material), possibly with compression thereof, gripped with a suitable instrument inserted into the perforation 7 and under With the help of a distraction instrument introduced into the cleared intervertebral space.
- bone chips bone graft or bone substitute material
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Neurology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
- Ceramic Engineering (AREA)
- Inorganic Chemistry (AREA)
- Prostheses (AREA)
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/CH1996/000303 WO1998009586A1 (de) | 1996-09-04 | 1996-09-04 | Zwischenwirbel-implantat |
US09/254,206 US6503279B1 (en) | 1996-09-04 | 1996-09-04 | Intervertebral implant |
US10/337,267 US6843805B2 (en) | 1996-09-04 | 2003-01-07 | Intervertebral implant |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0927011A1 true EP0927011A1 (de) | 1999-07-07 |
EP0927011B1 EP0927011B1 (de) | 2003-01-22 |
Family
ID=27178668
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP96927498A Expired - Lifetime EP0927011B1 (de) | 1996-09-04 | 1996-09-04 | Zwischenwirbel-implantat |
Country Status (6)
Country | Link |
---|---|
US (2) | US6503279B1 (de) |
EP (1) | EP0927011B1 (de) |
JP (1) | JP2000517221A (de) |
AT (1) | ATE231370T1 (de) |
DE (1) | DE59610079D1 (de) |
WO (1) | WO1998009586A1 (de) |
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-
1996
- 1996-09-04 DE DE59610079T patent/DE59610079D1/de not_active Expired - Lifetime
- 1996-09-04 AT AT96927498T patent/ATE231370T1/de not_active IP Right Cessation
- 1996-09-04 WO PCT/CH1996/000303 patent/WO1998009586A1/de active IP Right Grant
- 1996-09-04 EP EP96927498A patent/EP0927011B1/de not_active Expired - Lifetime
- 1996-09-04 JP JP10512080A patent/JP2000517221A/ja not_active Ceased
- 1996-09-04 US US09/254,206 patent/US6503279B1/en not_active Expired - Lifetime
-
2003
- 2003-01-07 US US10/337,267 patent/US6843805B2/en not_active Expired - Lifetime
Non-Patent Citations (1)
Title |
---|
See references of WO9809586A1 * |
Also Published As
Publication number | Publication date |
---|---|
ATE231370T1 (de) | 2003-02-15 |
WO1998009586A1 (de) | 1998-03-12 |
EP0927011B1 (de) | 2003-01-22 |
US6843805B2 (en) | 2005-01-18 |
DE59610079D1 (de) | 2003-02-27 |
JP2000517221A (ja) | 2000-12-26 |
US20030114932A1 (en) | 2003-06-19 |
US6503279B1 (en) | 2003-01-07 |
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